Urorec capsules
*Company:
Recordati Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 May 2025
File name
IE_Urorec_SmPC_06-2019.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.8 - Removal of Malta reporting information
Updated on 02 May 2025
File name
IE_Urorec_Leaflet_02-2025.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Section 4 - Removal of Malta reporting information
Section 6 - Removal of Malta local Representative Information
Change of Revision date 02/2025
Updated on 17 February 2023
File name
ie-pl-urorec-june2019.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 17 February 2023
File name
ie-spc-urorec-june2019.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 December 2019
File name
Urorec 4mg_8mg capsules - Leaflet - June 2019.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 6 - what the product looks like and pack contents
Updated on 20 December 2019
File name
Urorec 4mg_8mg capsules - SmPC - June 2019.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 December 2019
File name
Urorec 4mg_8mg capsules - SmPC - June 2019.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 December 2019
File name
PIL_14790_869.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 6 - what the product looks like and pack contents
Updated on 16 October 2014
File name
PIL_14790_869.pdf
Reasons for updating
- New PIL for new product
Updated on 16 October 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 03 January 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of manufacturer
- Addition of information on reporting a side effect.
Updated on 30 April 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
- Correction of spelling/typing errors
Updated on 29 February 2012
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 03 August 2011
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 25 October 2010
Reasons for updating
- Change to improve clarity and readability
- Change of distributor details
Updated on 03 September 2010
Reasons for updating
- New PIL for new product
Recordati Ireland Limited
Address:
Raheens East, Ringaskiddy, Co. Cork, IrelandMedical Information E-mail:
medinfo@recordati.co.ukTelephone:
+353 21 437 9400Fax:
+353 21 437 9280Medical Information Direct Line:
1800 303 351